Elranatamab for Multiple Myeloma

Overseen By Krisma Montalvo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must not be taking: Immunosuppressants

Disqualifiers: Active malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that your last systemic treatment should be at least 2 weeks or 5 half-lives before starting the trial, and you can take a maximum of 160mg of dexamethasone during screening, but at least 7 days before starting therapy.

What data supports the effectiveness of the drug Elranatamab for treating multiple myeloma?

Research shows that Elranatamab, a drug used for multiple myeloma, has been effective in patients who have tried other treatments before. In a study, 63.6% of patients responded to the drug, and many had a complete response, meaning their cancer was not detectable. The drug also showed promising results in terms of how long patients lived without the disease getting worse. ^{1 2 3 4 5}

How is the drug Elranatamab different from other treatments for multiple myeloma?

Elranatamab is unique because it is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T cells, activating the T cells to attack the cancer cells. It is administered subcutaneously (under the skin) and has shown promising results even in patients who have already received multiple other treatments. ^{1 2 3 4 6}

Research Team

Ah-Reum Jeong

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adults over 18 with relapsed/refractory Multiple Myeloma who've had 1-3 prior treatments but haven't received BCMA-directed CAR T-cell therapy. They must have measurable levels of myeloma proteins in their blood or urine and be able to perform daily activities (ECOG status 0, 1, or 2).

Inclusion Criteria

Provision of signed and dated informed consent form

My side effects from previous treatments have mostly gone away.

Serum pregnancy test negative at screening for females of childbearing potential

Exclusion Criteria

I have no active infections or have controlled them for at least 14 days.

Pregnancy or lactation

Known or suspected hypersensitivity to the study intervention or any of its excipients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab for relapsed/refractory multiple myeloma

1 year

Observation

Treatment-free observation period for patients with sustained MRD negative response for greater than 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Elranatamab

Trial Overview The study tests elranatamab's effectiveness on its own in patients whose Multiple Myeloma has returned after treatment or hasn't responded to previous therapies.

Participant Groups

Group I: Elranatamab Experimental Treatment 1 Intervention

Treatment with elranatamab

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

Elranatamab is a bispecific T cell engager that targets BCMA on multiple myeloma cells, effectively activating T cells to kill these cancer cells, and has received its first approval in the USA for treating adult patients with relapsed or refractory multiple myeloma after at least four prior therapies.

The approval was based on the drug's response rate and durability of response, with ongoing studies required to confirm its clinical benefits, indicating a promising new option for patients with difficult-to-treat multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab: First Approval. Dhillon, S.[2023]

Elranatamab, a bispecific antibody targeting BCMA and CD3, has shown promising results in treating relapsed refractory multiple myeloma, but its effectiveness in cases with central nervous system (CNS) involvement was previously unclear.

In a reported case, a 37-year-old male patient with CNS involvement of multiple myeloma was successfully treated with Elranatamab, suggesting potential for this therapy in challenging CNS-MM cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. Mutlu, YG., Yıgıt Kaya, S., Maral, S., et al.[2023]

In the phase 2 MagnetisMM-3 trial, elranatamab demonstrated a confirmed objective response rate of 61.0% in patients with relapsed or refractory multiple myeloma, indicating its efficacy as a treatment option.

The safety profile of elranatamab was manageable, with a reduction in grade 3-4 adverse events when switching from weekly to biweekly dosing, suggesting that this adjustment may enhance long-term safety without affecting treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Lesokhin, AM., Tomasson, MH., Arnulf, B., et al.[2023]

In the MagnetisMM-1 trial involving 88 patients with relapsed or refractory multiple myeloma, elranatamab demonstrated a significant overall response rate of 63.6%, with 38.2% of patients achieving a complete response or better, indicating its efficacy even in heavily pre-treated patients.

Elranatamab showed manageable safety with no dose-limiting toxicities during dose escalation, although some patients experienced cytopenias and cytokine release syndrome; the median progression-free survival was 11.8 months and overall survival was 21.2 months, suggesting promising durability of responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Bahlis, NJ., Costello, CL., Raje, NS., et al.[2023]

Elotuzumab, when combined with other treatments, significantly improved progression-free survival (PFS) by 14% and overall survival (OS) by 20% in multiple myeloma patients, based on a review of five randomized control trials involving 1,763 participants.

While Elotuzumab showed efficacy in relapsed/refractory multiple myeloma, it also increased the risk of serious adverse events, infections, and cardiac disorders, indicating a need for careful monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Elotuzumab combination therapy for patients with multiple myeloma: A systematic review and meta-analysis. Noori, M., Fayyaz, F., Rezaei, N.[2023]

Elotuzumab is an FDA-approved monoclonal antibody for multiple myeloma that targets SLAMF7, a protein found on myeloma and natural killer cells, enhancing the immune response against cancer cells.

In clinical trials, elotuzumab showed strong efficacy and a good safety profile when used with other treatments like immunomodulatory drugs and proteasome inhibitors, making it a promising option for multiple myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab for the treatment of multiple myeloma. Wang, Y., Sanchez, L., Siegel, DS., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Elranatamab: First Approval. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Elotuzumab combination therapy for patients with multiple myeloma: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Elotuzumab for the treatment of multiple myeloma. [2022]